اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
CLEVIPREX از شرکت CHIESI
New Drug Application (NDA): 022156
Company: CHIESI
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CLEVIPREX | CLEVIDIPINE | 25MG/50ML (0.5MG/ML) | EMULSION;INTRAVENOUS | Prescription |
None |
Yes | Yes |
| CLEVIPREX | CLEVIDIPINE | 50MG/100ML (0.5MG/ML) | EMULSION;INTRAVENOUS | Prescription |
None |
Yes | Yes |
| CLEVIPREX | CLEVIDIPINE | 125MG/250ML (0.5MG/ML) | EMULSION;INTRAVENOUS | Discontinued |
None |
Yes | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 08/01/2008 | ORIG-1 | Approval |
Type 1 – New Molecular Entity |
STANDARD |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022156s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/16/2021 | SUPPL-7 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022156s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022156Orig1s007ltr.pdf |
||
| 06/23/2015 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/08/2013 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/08/2011 | SUPPL-3 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022156s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022156s003ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/16/2021 | SUPPL-7 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022156s007lbl.pdf | |
| 12/08/2011 | SUPPL-3 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022156s003lbl.pdf |
نظرات کاربران